FDA approves first 'digital pill' to track patients

WASHINGTON | U.S. regulators have approved the first drug with a sensor that can track whether patients have taken their medicine.

Providing they sign a consent form, patients can allow up to four other people, including their doctors, caregivers, and family members, to access the data via a web-based portal.

Monday's FDA approval for Abilify MyCite is for treatment of schizophrenia, bipolar disorder and as an add-on treatment for depression in adults.

"Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or not occur", a statement from the FDA said.

According to The New York Times, medical noncompliance costs the United States $100 billion annually, mainly because failure to adhere to treatment leads to sicker patients who often require expensive hospitalization.

The Centers for Disease Control and Prevention estimate that "one half of patients in the USA stop taking their medications within one year of being prescribed".

The sensor in the pill is the size of a grain of salt, with no battery or antenna.

The application for aripiprazole with the embedded sensor was originally accepted by the FDA for review in September 2015, which was followed by a complete response letter requesting more information on the digital drug. An electrical signal is activated when the sensor comes in contact with stomach acid.

A patch worn by the patient transmits this information to their smartphone. In the drug's label, for instance, the FDA noted the wearable patch detects the IEM signal usually within 30 minutes following ingestion. The system is meant to integrate into individuals' lives, and individuals indicate through the app which member (s) of their care team can access information about their medication ingestion, activity, and self-reported mood and rest. If the MyCite app is unable to show if the pill was ingested, a repeat dose is not advised. Despite the concerns, the FDA is already anticipating a surge in approval requests for other digital pill systems.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, said in his statement on Abilify MyCite.

Ameet Sarpatwari, an instructor in medicine at Harvard Medical School, said the digital pill has the potential to improve public health, but warned it could foster more mistrust if used improperly.

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